Québec government covers LEMTRADA® for MS patients

The only second-line treatment for relapsing-remitting multiple sclerosis, given once a year for two years

MISSISSAUGA, ON, Oct. 1, 2014 /CNW/ - Genzyme, a Sanofi company, announced today that Québec's Institut national d'excellence en santé et services sociaux (INESSS) has recommended that LEMTRADA® (alemtuzumab) 12 mg be included on the provincial drug formulary under "Médicament d'exception" as second-line for people living with relapsing-remitting multiple sclerosis (RRMS). This announcement follows decisions by international Health Technology Assessment Agencies, such as NICE in the UK in May and PBAC in Australia in August 2014.

"We are pleased that the province of Québec is leading the way in accelerating access to treatments for Canadians living with MS," says Yves Savoie, president and CEO of the Multiple Sclerosis Society of Canada. "This announcement highlights the importance of having more treatment choices for individuals with MS to manage their disease."

Approved in Canada in December 2013, LEMTRADA® is a recombinant humanized monoclonal antibody. It is a selective immunomodulator indicated for the management of adult patients with RRMS, defined by clinical factors and imaging results, who have had an inadequate response to interferon beta or other disease-modifying therapies.

The reimbursement criteria are:

• "For the monotherapy treatment of people with relapsing-remitting multiple sclerosis (RRMS),
  • diagnosed according to the McDonald criteria (2010)
  • experiencing at least two relapses in the previous 2 years of which one must have taken place during the past year. In addition, one of them must have occurred while the patient was taking a DMT listed under RAMQ list of drugs for the treatment of this disease for at least six months under certain conditions
  • EDSS must be equal to or lower than 5.
• The authorization of the initial request is for a cycle of 5 consecutive days of treatment at a daily dose of 12 mg to cover the first year of treatment.
  
• To continue treatment after the first year, the physician must provide evidence of a beneficial effect on annual relapse rate in addition to a stabilization of the result on the EDSS or an increase of less than 2 points without exceeding 5.
  
• Authorization of the second request is for a cycle of 3 consecutive days of treatment at a daily dose of 12 mg given 12 months after the first cycle. Thus, the total allowed duration of treatment is 24 months."

"The Multiple Sclerosis Society of Québec welcomes the INESSS recommendation to add LEMTRADA® under Médicament d'Exception to Québec's drug formulary. We are delighted with this news since access to treatments for people with MS is paramount," says Louis Adam, General Manager, Multiple Sclerosis Society of Canada, Québec Division.

The INESSS recommendation is based on the Phase III study CARE MS II (Coles 2012) to evaluate the therapeutic value of LEMTRADA® and according to the Health Canada indication. The CARE MS II trial has shown that, as a second-line treatment, LEMTRADA® is more effective than interferon beta-1a in reducing the annual relapse rate and the time to onset of sustained accumulation of disability. LEMTRADA® with its novel mechanism of action will complement the range of therapeutic options for the patients suffering from RRMS.

"We are very pleased to learn that the transformative potential of LEMTRADA® will be available to all Québecers living with relapsing MS," says Peter Brenders, CEO of Genzyme Canada. "We applaud the Québec government for its leadership in health care, as this approval underscores LEMTRADA's capability to have a positive impact on the lives of MS patients."

As part of its commitment to those living with MS, Genzyme has developed the MS One to One™ program which provides comprehensive and effective support, particularly with regard to the procedures for reimbursement and administration, as well as providing educational resources. Staffed by dedicated MS nurses and highly trained representatives, MS One to One™ provides support for individuals living with MS, their healthcare providers, family and loved ones.

About MS in Canada
With 100,000 Canadians living with MS and three people newly diagnosed every day, Canada has one of the highest prevalence rates in the world. As most people are diagnosed with relapsing MS in their twenties and thirties, MS is the most common neurological disease affecting young adults in Canada.

About Genzyme, a Sanofi Company
Genzyme has pioneered the development and delivery of transformative therapies for patients affected by rare and debilitating diseases for over 30 years. We accomplish our goals through world-class research and with the compassion and commitment of our employees. With a focus on rare diseases and multiple sclerosis, we are dedicated to making a positive impact on the lives of the patients and families we serve. That goal guides and inspires us every day. Genzyme's portfolio of transformative therapies, which are marketed in countries around the world, represents groundbreaking and life-saving advances in medicine. As a Sanofi company, Genzyme benefits from the reach and resources of one of the world's largest pharmaceutical companies, with a shared commitment to improving the lives of patients. Learn more at www.genzyme.ca.

About Sanofi
Sanofi, a global and diversified healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients' needs. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and the new Genzyme

Genzyme® and LEMTRADA® are registered trademarks of Genzyme Corporation. All rights reserved.

SOURCE: Genzyme Canada

Media Contacts: Noëlle-Dominique Willems, Director Government Affairs and Market Access, Genzyme Canada, [phone], [email protected]; Jennifer Dolan, Cohn & Wolfe, [phone], [email protected]